James S. Bourdage

ORCID: 0009-0003-9000-627X
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About
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Research Areas
  • Biosimilars and Bioanalytical Methods
  • Monoclonal and Polyclonal Antibodies Research
  • Protein purification and stability
  • Clinical Laboratory Practices and Quality Control
  • Advanced Biosensing Techniques and Applications
  • Blood groups and transfusion
  • Biosensors and Analytical Detection
  • Animal Virus Infections Studies
  • Polyomavirus and related diseases
  • Amyloidosis: Diagnosis, Treatment, Outcomes
  • Poxvirus research and outbreaks
  • Veterinary medicine and infectious diseases
  • Viral Infections and Outbreaks Research
  • Viral Infections and Immunology Research
  • Radiopharmaceutical Chemistry and Applications
  • Sepsis Diagnosis and Treatment
  • CAR-T cell therapy research
  • Immunodeficiency and Autoimmune Disorders
  • Multiple Myeloma Research and Treatments
  • Health and Medical Research Impacts
  • Chronic Lymphocytic Leukemia Research
  • Plant Virus Research Studies
  • Enzyme Structure and Function
  • Bacillus and Francisella bacterial research
  • Drug Transport and Resistance Mechanisms

Merck (Germany)
2024

Bioanalytical Systems (United States)
2016-2019

Eli Lilly (United States)
2005-2009

Specifica (United States)
1996

Analytical Engineering (United States)
1995

W.E. Upjohn Institute for Employment Research
1990

Polyclonal antithymocyte globulin (ATGVantilym-phocyte and antilymphoblast globulins (ALG) antibodies have been used successfully in transplantation, aplastic anemia graft-versus-host disease. Flow cytometry has to analyze peripheral blood lymphocyte populations transplant patients receiving polyclonal ATG/ALG preparations for immunosuppression. Recent reports indicated clinical dose adjustment based on levels of patient's cells expressing various CD antigens. In vitro analysis individual...

10.1097/00007890-199504000-00020 article EN Transplantation 1995-04-01

Abstract Like other monoclonal antibodies, immune checkpoint inhibitors may be immunogenic in some patients, potentially affecting pharmacokinetics (PKs) and clinical outcomes. In post hoc analyses, we characterized antidrug antibody (ADA) development with avelumab monotherapy patients metastatic Merkel cell carcinoma (mMCC) from the JAVELIN 200 trial (first‐line [1L; N = 116] second‐line or later [≥2L; 88] cohorts) advanced urothelial (aUC) Bladder 100 (1L maintenance [ 350]) Solid Tumor...

10.1111/cts.13730 article EN cc-by-nc Clinical and Translational Science 2024-02-27

ABSTRACT Inhalation anthrax is a potentially lethal form of disease resulting from exposure to aerosolized Bacillus anthracis spores. Over the last decade, incidents spanning deliberate mailing B. spores incidental exposures in users illegal drugs have highlighted importance developing new medical countermeasures protect people who been exposed “anthrax spores” and are at risk disease. The New Zealand White rabbit (NZWR) well-characterized model that has pathogenesis clinical presentation...

10.1128/cvi.00240-12 article EN Clinical and Vaccine Immunology 2012-06-13

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) Miami, FL, USA 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. objective of this meeting for representatives meet and discuss scientific regulatory issues specific bioanalysis. selected at year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers,...

10.4155/bio.16.16 article EN Bioanalysis 2016-02-26

The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international member companies offering bioanalytical services. objective of this meeting for GCC members to meet and discuss scientific regulatory issues specific bioanalysis. discussed at closed forum included reporting data failed method validation runs, GCP clinical sample bioanalysis, extracted stability, biomarker assay validation, processed batch...

10.4155/bio-2017-5000 article EN Bioanalysis 2017-03-24

Over the last decade, use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they increasingly make critical decisions safety and efficacy. As regulatory agencies routinely making based on data, there been significant scrutiny validation methods. Contract research organizations regularly commercially available immunoassay kits validate However, adaptation such in a regulated environment presents challenges was...

10.4155/bio-2019-0072 article EN Bioanalysis 2019-04-01

The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international members offering bioanalytical services were attendance order to discuss scientific and regulatory issues specific bioanalysis. second CRO-Pharma Scientific Interchange Meeting 7 2017, which included Pharma representatives' sharing perspectives the topics discussed earlier week with members. at meetings cumulative stability evaluations, matrix 2016 US FDA...

10.4155/bio-2018-0014 article EN Bioanalysis 2018-04-01

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were attendance order to discuss scientific and regulatory issues specific bioanalysis. discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent findings case studies involving stability nonclinical immunogenicity....

10.4155/bio-2019-0131 article EN Bioanalysis 2019-06-01

Bovine somatotropin was studied with respect to thermal stability, quantitative denaturation kinetics, and refolding potential following using a panel of 6 monoclonal antibodies the Conformation-Sensitive Immunoassay (CSI). The antibody consisted 4 conformation-dependent 2 sequence-specific antibodies. Each revealed unique stability profiles for their respective epitopes suggesting that they each recognize different antigenic determinants. Comparing generated these allowed bovine be...

10.1074/jbc.271.24.14055 article EN cc-by Journal of Biological Chemistry 1996-06-01

IntroductionIn order to find out the frequency rates of domestic and wild animal bites as well evaluation prevalence rabies disease in human population Province Kerman, a retrospective study was designed analyze statistically collected recorded data related this project.Methods This conducted within framework MPVM student research projects by means collaboration between

10.1186/cc6424 article EN cc-by Critical Care 2008-01-01
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